Impact of COL7A1 Gene Therapy on SCC Recurrence in RDEB Skin

Last updated: April 14, 2025
Sponsor: Stanford University
Overall Status: Active - Recruiting

Phase

2

Condition

Carcinoma

Squamous Cell Carcinoma

Human Papilloma Virus (Hpv)

Treatment

BVEC

Clinical Study ID

NCT06731933
IRB-73906
  • Ages > 18
  • All Genders

Study Summary

The study objective is to see if BVEC induced C7 expression in Recessive Dystrophic Epidermolysis Bullosa (RDEB) skin following Squamous cell carcinoma (SCC) excision will normalize the invasive tumor microenvironment and reduce tumor recurrence.

Prevention of SCC's in the RDEB subjects will increase their life span.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosis of generalized Recessive dystrophic epidermolysis bullosa (RDEB)demonstrated by COL7A1 mutations

  2. Presence of biopsy proven squamous cell carcinoma (SCC)

  3. Ability to understand and the willingness to provide written informed consent.

  4. US based participants are willing to use beremagene geperpavec (BVEC)

  5. Subject is 18 years or older

  6. participant willingness to use an effective method of contraception

Exclusion

Exclusion Criteria:

  1. Inability to travel to site for study visit

  2. Subject is pregnant

  3. Subject has Metastatic SCC's or is on any current systemic treatment for SCC.

Study Design

Total Participants: 16
Treatment Group(s): 1
Primary Treatment: BVEC
Phase: 2
Study Start date:
March 28, 2025
Estimated Completion Date:
February 28, 2027

Connect with a study center

  • Azienda Ospedliero-Universitaia

    Bari,
    Italy

    Active - Recruiting

  • Stanford University

    Redwood City, California 94063
    United States

    Active - Recruiting

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